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Pioglitazone vs Vitamin E vs Placebo for Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS) (PIVENS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00063622
Recruitment Status : Completed
First Posted : July 3, 2003
Results First Posted : August 1, 2012
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Description
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Brief Summary:
The purpose of this study is to determine if therapy with pioglitazone or vitamin E will lead to an improvement in liver histology in non-diabetic adult patients with non-alcoholic steatohepatitis (NASH).

Condition or disease Intervention/treatment Phase
Liver Diseases Drug: Pioglitazone Dietary Supplement: Vitamin E Drug: Matching placebo Phase 3

Detailed Description:
The purpose of this study is to determine if therapy with pioglitazone or vitamin E will lead to an improvement in liver histology in non-diabetic adult patients with non-alcoholic steatohepatitis (NASH).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 247 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Research Network in Nonalcoholic Steatohepatitis: Pioglitazone vs. Vitamin E vs. Placebo for the Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)
Study Start Date : January 2005
Actual Primary Completion Date : June 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Pioglitazone
 Drug: Pioglitazone
30 mg daily
Other Name: Actos
Active Comparator: 2
Vitamin E
 Dietary Supplement: Vitamin E
800 IU daily
Other Name: Nature Made
Placebo Comparator: 3
Placebo Pioglitazone or Placebo Vitamin E
 Drug: Matching placebo
Daily


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Improvement in Non-alcoholic Fatty Liver Disease (NAFLD) Activity Defined by Change in Standardized Scoring of Liver Biopsies at Baseline and After 96 Weeks of Treatment. [ Time Frame: baseline and 96 weeks ]
    Total nonalcoholic fatty liver disease (NAFLD) activity was assessed on a scale of 0 to 8, with higher scores indicating more severe disease; the components of this measure include steatosis (assessed on a scale of 0 to 3), lobular inflammation (assessed on a scale of 0 to 3), and hepatocellular ballooning (assessed on a scale of 0 to 2). The primary outcome was an improvement in histological findings from baseline to 96 weeks, which required an improvement by 1 or more points in the hepatocellular ballooning score; no increase in the fibrosis score; and either a decrease in the activity score for nonalcoholic fatty liver disease to a score of 3 or less or a decrease in the activity score of at least 2 points, with at least a 1-point decrease in either the lobular inflammation or steatosis score.


Secondary Outcome Measures :
  1. Number of Participants With Improvement in Steatosis [ Time Frame: baseline and 96 weeks ]
    Steatosis is assessed on a scale of 0 to 3 with higher scores indicating more severe steatosis. This secondary outcome measure is the number of participants that experienced a decrease in steatosis score, which indicates improvement in steatosis.

  2. Number of Participants With Improvement in Lobular Inflammation [ Time Frame: baseline and 96 weeks ]
    Lobular inflammation is assessed on a scale of 0 to 3 with higher scores indicating more severe lobular inflammation. This secondary outcome measure is the number of participants that experienced a decrease in lobular inflammation score, which indicates improvement in lobular inflammation.

  3. Number of Participants With Improvement in Hepatocellular Ballooning [ Time Frame: baseline and 96 weeks ]
    Hepatocellular ballooning is assessed on a scale of 0 to 2 with higher scores indicating more severe hepatocellular ballooning. This secondary outcome measure is the number of participants that experienced a decrease in hepatocellular ballooning score, which indicates improvement in hepatocellular ballooning.

  4. Number of Participants With Improvement in Fibrosis [ Time Frame: baseline and 96 weeks ]
    Fibrosis is assessed on a scale of 0 to 4 with higher scores indicating more severe fibrosis. This secondary outcome measure is the number of participants that experienced a decrease in fibrosis score, which indicates improvement in fibrosis.

  5. Number of Participants With Resolution of Definite Nonalcoholic Steatohepatitis [ Time Frame: baseline and 96 weeks ]
    The criteria for nonalcoholic steatohepatitis was definite or possible steatohepatitis (assessed by a pathologist) with an activity score of 5 or more, or definite steatohepatitis (confirmed by two pathologists) with an activity score of 4. This secondary outcome measure is the number of participants who met this definition at baseline and did not meet this definition after 96 weeks of treatment and thus had a resolution of steatohepatitis.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Histologic evidence of NASH based on a liver biopsy obtained within 6 months of randomization.
  • Age 18 years or older
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00063622


Locations
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United States, California
University of California, San Diego
San Diego, California, United States, 92103
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Missouri
St. Louis University
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44109
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00063622    
Other Study ID Numbers: NASH - ADULT (IND)
U01DK061730 ( U.S. NIH Grant/Contract )
First Posted: July 3, 2003    Key Record Dates
Results First Posted: August 1, 2012
Last Update Posted: April 6, 2018
Last Verified: August 2012
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Non alcoholic steatohepatitis
Steatohepatitis
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Vitamin E
Pioglitazone
Vitamins
 Micronutrients
Physiological Effects of Drugs
Hypoglycemic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents